(ORBEX) Randomized, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of Oral Bacterial Extract for the prevention of wheezing lower respiratory tract illness

The Oral Bacterial Extract (ORBEX) Study is a three year study with the goal of identifying if a daily capsule of Broncho-Vaxom®will help prevent or delay young children from developing wheezing or asthma like symptoms. Broncho-Vaxom has already been used by 43 million children in countries all over the world.

 

Why is this study being done? 

This research is being done to find out if Broncho-Vaxom® given to high-risk infants for 10 consecutive days each month over a two year period will prevent or reduce wheezing illnesses in the third year when the child is not taking it. Broncho-Vaxom® has been used safely in other countries all over the world; however, it has not been approved by the U.S. Food and Drug Administration for use in the U.S. Therefore, the use of Broncho-Vaxom® for this study is considered investigational.

Broncho-Vaxom® is a mix of components of different bacteria that are often responsible for respiratory infections. It works like an immunization to stimulate your child’s immune system in order to increase the body’s natural defenses against a wide number of respiratory bacteria that cause children to have respiratory illnesses.

How many people will take part in this study? 

The University of Arizona is one of 7 clinical centers in the U.S. doing this study. Approximately 1076 children will participate in the study nationwide. About 154 children will be enrolled at the University of Arizona.

The ORBEX Study is limited to participants who meet the following requirements:
• Child is between the ages of 5 - 17 months
• Must meet at least one of the following criteria
• One of the child’s parents has asthma or has been diagnosed with asthma in the past
• Child has been diagnosed with eczema
• At least one parent/legal guardian who can communicate with the study staff in English or Spanish and has a working cell phone.
 
Contact Information: 
Janette Priefert
(520) 626-5554
 
Ian Thomas
(520) 626-3569
 
 
Principal Investigator(s): 
Fernando Martinez, MD
Wayne Morgan, MD
Study Status: 
Currently Enrolling
Sponsor: 
National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH)